HemCon, Inc. PA-08-051 Chitosan Endoluminal Hemostatic Dressing Project Summary Abstract P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy Abstract The goal of this proposal is to demonstrate Phase I feasibility of a chitosan endoluminal hemostatic dressing (CEHD) that can be delivered through a Foley catheter to control and prevent urethral bleeding in a swine model. This swine model is a model of efficacy of blocking hemorrhage associated with transurethral resection of the prostate (TURP). TURP is the first line surgical treatment for benign prostate hyperplasia (BPH). TURP is performed about 100,000 times per year in the US. Post-operative hemorrhage after TURP is one of the major causes of prolonged catheterization and hospitalization, occurring in 6-10% of patients. Our device will be used to place a relatively inexpensive proprietary bandage via the catheter to prevent prolonged bleeding. This would allow for early catheter removal, improved patient comfort, accelerated recovery and significantly reduced hospital costs due to shorter hospital stays. Proprietary chitosan based dressings have been developed by HemCon and are FDA approved for controlling hemorrhage, especially on the battlefield. We have adapted the HemCon dressing as the CEHD to enable it to be used to control bleeding and facilitate surgery in the TURP procedure. Modifications to the HemCon dressing have been reduction in wall thickness (from 1.2 mm to ~200 <m) and improvement in resistance to dissolution. In this Phase I proposal we will: i) further refine the CEHD so that it can be applied by a Foley catheter to the resected prostrate surface to stay in place for up to 72 hours to control blood flow in the presence of urine;and ii) test the efficacy of the bandage by comparing severity and duration of hematouria in the swine model of TURP. Feasibility criteria in this study will be: i) the CEHD demonstrates significantly reduced bleeding in the first 24 hours compared to current standard of practice;ii) there is no significant enhancement in injury infection or inflammation in the CEHD group compared to standard of practice;iii) the CEHD can be removed by dissolution with a low pH irrigation solution. Phase II studies will lead to an FDA submission for clinical trials. PUBLIC HEALTH RELEVANCE: HemCon Medical Technologies, Inc. PA-08-051 Chitosan Endoluminal Hemostatic Dressing Project Narrative P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy Project Narrative Bleeding from prostatic cavity is the major complication in resection of enlarged prostatic gland tissue for the treatment of benign prostatic hyperplasia (BPH). Prolonged urethral catheterization due to significant post-operative bleeding mostly causes discomfort of the patients and increases the risk of urinary infection and other chronic complications. The motivation of this project, based upon our successful prototype of chitosan hemostatic dressing, is to develop an innovative endoluminal chitosan hemostatic dressing to control and prevent the prostatic bleeding and shorten the catheterization time after prostatic surgery. Our long-term goal is to provide a safe, effective and convenient technique to treat and prevent the bleeding from prostatic surgeries.